EYWA FDA Approval ANDA 214426

ANDA 214426

EYWA

FDA Drug Application

Application #214426

Application Sponsors

ANDA 214426EYWA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORAL5MEQ0POTASSIUM CITRATEPOTASSIUM CITRATE
002TABLET, EXTENDED RELEASE;ORAL10MEQ0POTASSIUM CITRATEPOTASSIUM CITRATE
003TABLET, EXTENDED RELEASE;ORAL15MEQ0POTASSIUM CITRATEPOTASSIUM CITRATE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

EYWA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214426
            [companyName] => EYWA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CITRATE","activeIngredients":"POTASSIUM CITRATE","strength":"5MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CITRATE","activeIngredients":"POTASSIUM CITRATE","strength":"10MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POTASSIUM CITRATE","activeIngredients":"POTASSIUM CITRATE","strength":"15MEQ","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/19\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-19
        )

)

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